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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Allergan Sales, LLC: Combigan Ophthalmic Solution Recalled for Manufacturing Deviations

Agency Publication Date: March 22, 2019
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Summary

Allergan Sales, LLC is recalling 72 bottles of Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% because of deviations from Current Good Manufacturing Practice (cGMP) requirements. This prescription eye medication is used to lower pressure in the eyes for conditions like glaucoma. Because the manufacturing standards were not met, the safety and quality of the medication in this specific batch cannot be guaranteed. Consumers should check their bottles for the specific lot number listed below and contact their healthcare provider.

Risk

Manufacturing deviations indicate that the product was not produced under strictly controlled conditions, which could potentially lead to issues with the medication's potency, purity, or sterility. While no specific injuries were reported in this voluntary recall, using compromised ophthalmic solutions can pose a risk of irritation or ineffective treatment of eye pressure.

What You Should Do

  1. Check your prescription bottle label for Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% in the 5 mL size.
  2. Verify if your bottle belongs to Lot#: 99946 with an expiration date of January 16, 2021 and NDC 0023-9211-05.
  3. If your product matches this lot number, contact your healthcare provider or pharmacist for guidance on obtaining a replacement.
  4. Return any unused bottles from this lot to the pharmacy where you purchased them for a refund.
  5. Contact Allergan Sales, LLC at their Waco, Texas facility or via their standard customer service channels for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% (5 mL)
Model:
NDC 0023-9211-05
Recall #: D-1056-2019
Lot Numbers:
99946 (Exp. January 16, 2021)
Date Ranges: Expiration Date: January 16, 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82424
Status: Resolved
Manufacturer: Allergan Sales, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 72 bottles
Distributed To: Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.